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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, patient transfer, powered
Product CodeFRZ
Regulation Number 880.6775
Device Class 2


Premarket Reviews
ManufacturerDecision
DIACOR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2
2016 2 2
2017 3 3
2018 2 2
2019 2 2
2021 3 3
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 4 4
Deflation Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Use of Device Problem 2 2
Infusion or Flow Problem 1 1
Excess Flow or Over-Infusion 1 1
Product Quality Problem 1 1
Device Operates Differently Than Expected 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1
Contamination 1 1
Unintended System Motion 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 7 7
Death 3 3
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Information 2 2
Bone Fracture(s) 2 2
Pain 2 2
High Blood Pressure/ Hypertension 1 1
Hip Fracture 1 1
Head Injury 1 1
Abrasion 1 1
Injury 1 1
Loss of Range of Motion 1 1
Insufficient Information 1 1
Hyperglycemia 1 1
Physical Entrapment 1 1
Unspecified Tissue Injury 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
Full thickness (Third Degree) Burn 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Sustainability Solutions II Aug-11-2023
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